2023-506715-18-00招募中3 期
Circulating tumour DNA based decision for adjuvant treatment in colon cancer stage II evaluation (CIRCULATE) AIO-KRK-0217.
Technische Universitat Dresden141 个研究点 分布在 2 个国家目标入组 140 人开始时间: 2024年4月17日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 140
- 试验地点
- 141
- 主要终点
- Disease free survival of ctDNA positive patients randomised to “chemo- therapy” vs. “follow-up”, measured from randomisation to any recur- rence, metastasis, second colorectal or non colorectal cancer and death from any cause. The primary endpoint will be tested in all randomised ctDNA positive patients and be evaluated by a stratified log rank test.
研究概览
简要总结
The study evaluates the adjuvant therapy in patients with colon cancer UICC stage II. To compare the disease free survival (DFS) in patients who are positive for ctDNA (ctDNApos) after the resection of the primary tumour with vs. without adjuvant therapy.
研究设计
- 分配方式
- Randomized
- 主要目的
- Randomisation
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Resected colon cancer stage II, OR Resected rectal cancer stage II, if there was no indication for radiotherapy (i.e. due to the localisation in the upper third of the rectum), so that the treatment follows the recommendations for colon cancer. Patients, in whom the tumour stage is not yet know, can be enrolled into the screening.
- •Signed informed consent for the screening and the randomised phase
- •Known microsatellite or mismatch repair status
- •Confirmation, that the ctDNA result is available
排除标准
- •Patients with known microsatellite instability (MSI-H) or mis- match repair deficiency (dMMR)
- •Colon or rectal cancer with UICC stage III or IV
- •Second cancer, except: simultaneous or metachronous colon or rectal cancer with UICC stage ≤ I, OR curatively treated basal cell carcinoma or squamous cell carcinoma of the skin and in-situ cervical carcinoma OR tumours with a disease free survival of more than five years
- •Contra indications for chemotherapy, especially: a) Leukocytes < 3,0 Gpt/l b) Neutrophil granulocytes < 1,5 Gpt/l c) Thrombocytes < 100 Gpt/l d) ALAT or ASAT > 3 x ULN e) Creatinine clearance (calculated according Cockcroft- Gault) < 30 ml/min
- •Comorbidities relevantly interfering with the prognosis of the patients, i.e.: a) heart insufficiency NYHA III/IV b) relevant coronary heart disease, c) Diabetes mellitus with late sequelae
- •Organ, stem cell or bone marrow transplantation
- •Known hypersensitivity to capecitabine. In case of known hypersensitivity to oxaliplatin, the patients can participate, but not receive oxaliplatin.
- •Medication with brivudine, sorivudine or analogues in the last four weeks before planned treatment start.
- •Known biallelic or homozygous dihydropyrimidine dehydro- genase (DPD)-deficiency
- •Acute infections
- •Known HIV- infections, known active hepatitis B or C- infection
- •Known clinical high risk situation if it is regarded as certain in- dication for an adjuvant chemotherapy
- •Participation at another interventional study for medical treat- ment during the last four weeks before randomisation
- •Neoadjuvant therapy before resection
- •Patients, in whom the randomisation or chemotherapy is un- feasible due to logistic reasons (travel distance, compliance)
- •Women of childbearing potential and men with partner with childbearing potential who are not willing to take appropriate precautions to avoid pregnancy with a highly effective method in case they are randomised to “chemotherapy”
- •Patients, who have an obvious contra-indication for adjuvant chemotherapy (i.e. due to the performance status, comorbid- ity, active second cancer or age) It should be considered that patients with an age of more than 75 years frequently not fulfil criteria for adjuvant chemotherapy
- •R1- or R2- status. (Patients with [still] unknown R-status can be screened)
- •Patients, in whom the randomisation or chemotherapy is un- feasible due to logistic reasons (travel distance, compliance)
- •Age < 18 years
- •Pregnant or breast feeding patients
- •R1- or R2- status, or unknown R- status (Rx)
- •Number of investigated lymph nodes < 10 5) WHO performance status ≥ 2
结局指标
主要结局
Disease free survival of ctDNA positive patients randomised to “chemo- therapy” vs. “follow-up”, measured from randomisation to any recur- rence, metastasis, second colorectal or non colorectal cancer and death from any cause. The primary endpoint will be tested in all randomised ctDNA positive patients and be evaluated by a stratified log rank test.
Disease free survival of ctDNA positive patients randomised to “chemo- therapy” vs. “follow-up”, measured from randomisation to any recur- rence, metastasis, second colorectal or non colorectal cancer and death from any cause. The primary endpoint will be tested in all randomised ctDNA positive patients and be evaluated by a stratified log rank test.
次要结局
- Overall survival in ctDNApos patients with adjuvant therapy vs follow-up, measured from randomisation to death from any cause, in all randomised ctDNA positive patients and be evalu- ated by a stratified log rank test.
- Disease free survival in ctDNAneg patients randomised to follow up (rate of patients disease free and alive 3 years after randomisation according to Kaplan-Meier estimation with 95% CI, intention-to-treat analysis). Any recurrence, metastasis, second colorectal or non-colorectal cancer and death from any cause is regarded as event
- Overall survival in ctDNAneg patients randomised to “follow up” (rate of patients alive after 5 years after randomisation according to Kaplan-Meier estimation with 95% CI).
- Disease free and overall survival of ctDNApos vs. ctDNAneg pa- tients randomized to „follow-up“ (measured from randomisation to the event in an intention-to-treat analysis by stratified log rank test). Any recurrence, metastasis, second colorectal or non-colorectal cancer and death from any cause are regarded as event for DFS. Death of any cause will be regarded as event for overall survival.
- Site of metastases (lymph node vs. peritoneal/local recurrence vs other) in ctDNApos vs. ctDNAneg patients who have a recur- rence / metastases.
- Frequency of adverse events from start of chemotherapy until 30 days after chemotherapy (descriptive analysis for patients randomised to “chemotherapy” who have received at least one dose of chemotherapy).
- Rate of patients in which ctDNA becomes non-measurable during or after chemotherapy (measured in ctDNApos patients receiving chemotherapy) and time to the first negative sample
- ctDNA level before recurrence
- DFS according to ctDNA level at time of enrolment
- Correlation of further molecular tissue and plasma marker to the risk of recurrence or metastases or the effect of chemo- therapy (exploratory analysis)
研究者
研究点 (141)
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